Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

NCT01466777 | Unknown

• 1 other identifier: R10081
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients. The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account. The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer. Secondary endpoints include:

1. 1.bleeding
2. 2.complications
3. 3.conversions
4. 4.number of pelvic lymph nodes

Conditions

Endometrium Cancer

Keywords

Endometrium cancer; Robotic-assisted laparoscopy; Traditional laparoscopy; Laparoscopic surgery; Treatment; Operation time; Bleeding; Complications; Conversions; Pelvic lymph node

Outcome Measures

Primary Outcomes (1)

• the operation time

  From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours

Secondary Outcomes (4)

• bleeding

  Duration of hospital stay, an expected average of 5 weeks

• Number of participants with adverse events

  Duration of hospital stay, an expected average of 5 weeks

• Pain

  Duration of hospital stay, an expected average of 5 weeks

• pelvic lymph node volumes

  Duration of hospital stay, an expected average of 5 weeks

Study Arms (2)

traditional laparoscopic surgery type

ACTIVE COMPARATOR

Procedure: Traditional surgery type

Robotic assisted operation type

EXPERIMENTAL

Procedure: Robotic assisted laparoscopic surgery

Interventions

Traditional surgery type PROCEDURE

Traditional laparoscopic surgery for endometrial cancer

traditional laparoscopic surgery type

Robotic assisted laparoscopic surgery PROCEDURE

Robotic assisted laparoscopic surgery for endometrial cancer

Robotic assisted operation type

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
• Gr 1 and 2 differentiation type

You may not qualify if:

• The operation cannot be made with an laparoscopy operation
• Age more than 85 years or young under 30 years patient

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, P.O.Box 2000, 33521, Finland

Location

Related Publications (1)

• Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073.

  PMID: 28937446 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

FI (1)